(252 days)
Not Found
No
The summary describes a mechanical device for vascular access and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
A therapeutic device is one that treats a disease or condition. This device is described as an introducer for diagnostic angiographic procedures, and its intended use is to provide vascular access for cardiovascular devices, not to directly treat a medical condition.
No
The device is an introducer, which is a tool used to facilitate the introduction of other devices (like catheters and guidewires) for diagnostic angiographic procedures, rather than performing a diagnostic function itself.
No
The device description clearly states it is a "disposable device" and describes physical characteristics and performance studies related to a physical catheter introducer, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide percutaneous vascular access for introducing cardiovascular devices. This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a "Percutaneous Catheter Introducer" used in "diagnostic angiographic procedures." While angiography is a diagnostic imaging technique, the introducer itself is a tool for accessing the vascular system, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device facilitates access to the body for other procedures, but it doesn't perform a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Adam Spence Corp. Percutaneous Catheter Introducer (PCI) is a disposable device intended for use in diagnostic angiographic procedures. The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.
Product codes
74 DYB
Device Description
The Adam Spence Corp. Percutaneous Catheter Introducer (PCI) is a disposable device intended for use in diagnostic angiographic procedures. It is designed to provide percutaneous vascular access while minimizing blood backflow during the introduction of cardiovascular devices like catheters and guide wires. It is available in 4 through 9 French sizes, is sterile and bulk packaged, and is sterilized using Ethylene Oxide Gas with a shelf life of 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The summary of performance studies includes:
- Tensile properties: Exceeds Requirement
- Valve/Sheath Leak: No Leakage
- Insertion/Withdrawal: Substantially Equivalent to Predicate
- Air Aspiration: Greatly Exceeded Predicate Device
- Tip Peelback: No Damage or Peelback: Lower average insertion force required to puncture skin than predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows a date, "JUL 15 1999". The month is July, the day is the 15th, and the year is 1999. The text is written in a simple, sans-serif font and is easily readable. The date is likely a stamp or a handwritten note.
Adam Spence Corporation
1746 Route 34, P.O. Box 1467, Wall, NJ 07719, (732) 681-7070, Fax, (732) 681-1503
510(k) SUMMARY
Trade Name: Adam Spence Corp. Percutaneous Catheter Introducer
Common or usual Name: Catheter Sheath Introducer System
Classification Name: Catheter, Introducer, Class II device (per 21 CFR 870.1340)
Equivalent Device: Daig Corporation Fast-Cath™ Transseptal Catheter Introducer, K964518
Contact Name: Carol Rosenbloom
Description and Intended Use: The Adam Spence Corp. Percutaneous Catheter Introducer (PCI) is a disposable device intended for use in diagnostic angiographic procedures. The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.
Performance Standards:
- Performance standards have not been established under Section 514 of the Food, . Drug and Cosmetic Act.
- ANSI MD70.1-1983. American National Standard for Medical Material Luer Taper ● Fittings - Dimensional Requirements for Luer Lock Fittings
- ISO/DIS 11070.2: Sterile, Single-Use Intravascular Catheter Introducers, Sections 4. . 7, 9, and 10.
Biocompatibility: All appropriate biocompatibility tests have been performed per ISO 10993, Biological Evaluation of Medical Devices (Per General Program Memorandum #G95-1)
Summary of Substantial Equivalence: The Adam Spence Percutaneous Catheter Introducer has the same intended use as other catheter sheath introducers on the market (ie., Daig Fast-Cath™ Hemostasis Introducer.) Additionally, based on the technological characteristics and performance testing the Adam Spence Percutaneous Catheter Introducer is substantially equivalent in its basic design, construction, material, safety, efficacy and intended use to currently marketed catheter sheath introducer systems.
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| SUMMARY OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| FEATURE | ADAM SPENCE PCI | PREDICATE DEVICE |
| Manufacturer | Adam Spence Corporation | Daig Corporation |
| Sterile Packaging | Sterile and Bulk Packaged | Sterile Pack |
| Sterilization Method | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Shelf Life | 3 Years | 3 Years |
| Available Sizes | 4 though 9 French size | 4 through 9 French size |
| Tensile properties | Exceeds Requirement | Exceeds Requirement |
| Valve/Sheath Leak | No Leakage | 4 Fr. leaked after dilation |
| Insertion/Withdrawal | Substantially Equivalent to Predicate | Acceptable |
| Air Aspiration | Greatly Exceeded Predicate Device | Acceptable |
| Tip Peelback | No Damage or Peelback: | |
| Lower average insertion | ||
| force required to puncture | ||
| skin than predicate device. | No Damage or Peelback: | |
| Higher average insertion | ||
| force required to puncture | ||
| skin than ASC PCI. |
Prepared By: Carole A. Lusinaka Date: 4/20/99
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, with three wavy lines representing the body and a head-like shape at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Ms. Carol Rosenbloom Adam Spence Corporation 1746 Route 34 P.O. Box 1467 Wall, NJ 07719
Re: K983940 EZ-Intro™ Percutaneous Catheter Introducer Regulatory Class: II (two) Product Code: 74 DYB Dated: April 16, 1999 Received: April 21, 1999
Dear Ms. Rosenbloom:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Carol Rosenbloom
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
STATIENTENT OF INDICATIONS FOR USE
The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for The Flain Spence Porcalise while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
: